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Duloxetine Decreased Chemotherapy-Induced Peripheral Neuropathic Pain

Duloxetine significantly reduced pain associated with chemotherapy-induced peripheral neuropathy in patients with cancer. 

JAMA 2013 Apr 02;309(13)1359-1367, EM Lavoie Smith, H Pang, C Cirrincione, et al


Commentary by Lee S. Schwartzberg , MD, FACP

Chemotherapy-induced peripheral neuropathy (CIPN) has emerged as perhaps the most ubiquitous and quality-of-life dampening toxicity of common chemotherapy programs. In breast and colorectal cancer, where taxanes and platinums are used routinely and the large majority of patients survive for decades, even mild ongoing daily symptomatic toxicity can be devastating. So far, development of therapeutics to prevent this complication has been elusive. We have better success with treatment of painful CIPN, as this randomized double-blind crossover study of duloxetine attests. The trial focused on painful neuropathy, rather than the far more commonly experienced numbness, tingling, and dysesthesias, which may represent more of a quantitative than qualitative difference. Encouragingly, duloxetine demonstrated a moderately strong effect on painful CIPN. There was also a trend toward benefit in the self-reported non-painful CIPN component. Some patients did not tolerate the drug, which remains an issue for any supportive-care measure treating toxicity. Based on this trial and prior studies, duloxetine should be considered a proven intervention for patients who have persistent CIPN during or after completion of neurotoxic chemotherapy.


PracticeUpdate Editorial Team

Painful peripheral neuropathy is a frequent adverse effect of several types of chemotherapy, and has no known effective treatments. The neurotransmitters serotonin and norepinephrine suppress transmission of painful stimuli to the spinal cord. Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor that has been shown in phase III studies to reduce the pain of diabetic neuropathy. This phase III double-blind, randomized, placebo-controlled crossover clinical trial evaluated the efficacy and safety of duloxetine as treatment for chemotherapy-induced painful neuropathy in patients with cancer.

Patients were included if they had chemotherapy-induced peripheral neuropathy. Patients could have any cancer, and had been treated with paclitaxel, oxaliplatin, docetaxel, nanoparticle albumin-bound paclitaxel, or cisplatin. Patients were randomly assigned to receive 60 mg of duloxetine daily during the initial treatment period and then placebo in the crossover period (group A), or placebo in the initial period and then duloxetine in the crossover period (group B). The initial period lasted for 5 weeks (weeks 1–5), followed by a 2-week washout period, followed by the crossover period (weeks 8–12). During the first week of active treatment, patients received 30 mg daily of duloxetine, followed by 60 mg daily in the remaining 4 weeks of active treatment.

A total of 231 patients enrolled, and 220 received treatment. The only significant difference between groups at baseline was in mean pain score, which was greater in group A (duloxetine first) than in group B (6.1 vs 5.6; P = .02).

Following the first treatment period, duloxetine resulted in a larger decrease in pain compared with placebo (mean change score 1.06 vs 0.34; P = .003). During this period, a reduction in pain was reported by 59% of patients in the duloxetine group and 38% in the placebo group; in the duloxetine group, 30% reported no change in pain and 10% reported increased pain. The relative risk of 30% pain reduction was 1.96 (95% CI) in the duloxetine group and 5% in the remaining two groups. Patients previously treated with platinum-based chemotherapies reported better outcomes than those treated with taxanes (average pain score 1.06 vs 0.19). In addition, duloxetine significantly reduced the amount of pain interference with daily functioning (P = .01); improved pain-related quality of life (P = .03); and resulted in a greater proportion of patients who reported reductions in numbness and tingling (41% vs 23%). During the crossover period, when compared with placebo, duloxetine significantly reduced pain (change in mean pain score 0.41 vs 1.42; P < .001), and reduced the proportion of patients reporting numbness and tingling (41% vs 23%). There was no significant effect of treatment order on pain scores. The most common adverse effects associated with duloxetine were fatigue, insomnia, and nausea. There were no hematologic or grades 4 or 5 adverse events.

Duloxetine significantly reduced pain associated with chemotherapy-induced peripheral neuropathy in patients with cancer.

JAMA : The Journal of the American Medical Association

Effect of Duloxetine on Pain, Function, and Quality of Life Among Patients With Chemotherapy-Induced Painful Peripheral Neuropathy: A Randomized Clinical Trial 

JAMA 2013 Apr 02;309(13)1359-1367, EM Lavoie Smith, H Pang, C Cirrincione, et al 


This entry was posted on April 20, 2013 by in Uncategorized and tagged , , .

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